Kornimate/medical-research-clean huggingface dataset:
toxicity of perirenal fat in overweight or obese subjects: a pathophysiological link between uric acid stones and renal ammonium formation

Conditions: Uric Acid Stones

Summary: patients who are overweight or obese, diabetic or not, share with those who are suffering from uric stones the same way to remove abnormal acidity of the body in urine, ie a kidney ammoniogenesis default. this results in an overly acidic urine ph which is directly pathogenic in people predisposed to develop uric stones because the precipitation of urate soluble uric acid is accelerated in acid medium. excess visceral fat, particularly perirenal, this defect may promote formation of renal ammonium. indeed, the perirenal fat is adjacent to the renal cortex and shares with it a common arterial supply via the plexus turner. adipokines and fatty acids of the perirenal fat are predisposed to gain the renal cortex, seat of the ammoniogenesis. in humans the pathogenic role of the perirenal fat is demonstrated in chronic kidney disease and essential hypertension. however, the amount of fat and perirenal that of intra-abdominal fat are positively correlated. investigators hypothesis is that the perirenal fat also exert a pathogenic role in uric because of anatomical links between kidney stones and greasy environment and because excess fatty acids reaching the renal cortex decreases ammoniogenesis in an animal model metabolic syndrome. for the test, the investigators will compare the amount of fat and perirenal renal ability to form ammonium in patients with uric or calcium lithiasis taking into account the amount of intra-abdominal fat.


Eligibility criteria:
inclusion criteria: * urolithiasis uric defined by more than 90% of uric acid anhydrous and / or dihydrate or calcium lithiasis defined by more than 90% mono calcium oxalate and / or dihydrate, and / or carbapatite and / or brushite; * overweight and obesity defined by 25 \<bmi \<35 kg / m2 exclusion criteria: * staghorn lithiasis, stones struvite or cystine; * primary hyperparathyroidism; * hyperthyroidism; * any form of calcium or uric lithiasis secondary; * abnormal kidney structure (cysts, cortical thinning, kidney tumor);

Keywords: renal ammonium ;uric acid
a study evaluating the pharmacokinetics of ceftobiprole when taken by obese patients

Conditions: Obesity; Staphylococcal Skin Infections; Streptococcal Infections

Summary: the primary objective of this study is to compare the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole in morbidly obese patients and non-obese patients. the secondary objectives are to assess the pharmacodynamics (the study of the action or effects a drug has on the body) and to assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.

this is an open-label (all people involved know the identity of the intervention), parallel-group, phase 1 study in morbidly obese and non-obese men and women. a total of 25 patients (12 morbidly obese and 13 non-obese) patients will be enrolled in the study. morbidly obese and nonobese patients are matched individually 1:1 by age (±10 years), sex, and renal function (as defined by creatinine levels in the urine). there are 4 phases in the clinical study: the pretreatment (screening/baseline) phase of up to 21 days; the 2-day open-label treatment phase when each patients receives a single 2-hour intravenous (directly into the vein) infusion of ceftobiprole 500 mg followed by multiple (up to 15) blood and urine samples drawn over the 24 hours following study drug administration; and the follow-up phase of approximately 1 week after the last blood sample when each patient will be monitored by telephone for development of new adverse events and assessment of ongoing adverse events. each patient receives a single 2-hour infusion (directly into the vein) of ceftobiprole 500 mg

Eligibility criteria:
inclusion criteria: * body mass index (bmi) =or \> 40 kg/m2 or normal bmi between 18-30 * blood pressure 90-140 mm * non-smoker exclusion criteria: * history of medically significant illness * uncontrolled hypertension * uncontrolled high blood cholesterol and triglycerides

Keywords: obesity, ceftobiprole skin infections staphylococcal skin infections bacterial skin infections streptococcal infection
menstrual cycle characteristics of healthcare professionals

Conditions: Menstrual Irregularity; Covid 19

Summary: the covid-19 pandemic has impacted healthcare workers physically and psychologically. the aim of this study is to examine whether there is a change in menstrual cycle characteristics during pandemia. the aim of this study is to investigate whether there is an association between covid infection and menstrual cycle changes.

the covid-19 pandemic has impacted healthcare workers physically and psychologically. healthcare workers have ben required to work under stressful conditions and take difficult decisions involving ethical implications. increasing work demands on healthcare professionals conflict with their duties to family and friends, which causes psychological stress. all of these factors may negatively affect their menstrual cycle. the aim of this study is to examine whether there is a change in menstrual cycle characteristics during pandemia. second aim is to investigate whether there is an association between covid 19 infection and menstrual cycle changes. this cross-sectional study is conducted with healthy female participants who are working at haydarpasa numune research and training hospital in turkey. the researcher investigates the characteristics of menstrual cycle in female healthy workers employed in covid 19 pandemic inpatient and outpatient clinics. the participants who are sure about their pertinent information are enrolled in the study. the exclusion criteria includes pregnancy, history of hysterectomy, oophorectomy, diseases like asherman's syndrome and also history of endocrine disorders (progesterone deficiency, thyroid disorders and diabetes mellitus), oral contraceptive use, malignancy, primary amenorrhea, menopause and lactation. after informed consent, detailed information is collected using structured questionnaires about their reproductive factors and menstrual cycles by direct interviews. the questionnaire contains questions about age, work experience, marital status, height, weight, working hours, use of medication, menstrual cycle characteristics (including cycle duration, duration and amount of bleeding, bleeding during the cycle, regular or irregular menstrual cycles) and dysmenorrhea. also, the difference in menstrual cycle characteristics between covid positive and negative healthcare professionals is investigated.

Eligibility criteria:
inclusion criteria: * working at covid 19 pandemic hospital * being at between 18 and 47 years old * having menstruation exclusion criteria: * oral contraceptive users * pregnants * having malignancy * having primary amenorrhea * being at menopause * lactation

Keywords: health care professionals menstrual cycle covid 19 pandemia
a pragmatic trial of dietary programs in people with multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: this is a pragmatic, single-blinded randomized trial of improving adherence to dietary interventions in patients with ms who are receiving monthly natalizumab infusions.

ms affects at least 400,000 people in the us alone, and its incidence has increased in the past 50 years, likely due to changing environmental risk factors. recent research suggests that diet may be a critical factor in the development of ms. the "western diet", high in sugar, fat, and salt, may influence ms risk and progression by directly affecting the immune system, altering gut bacteria, and changing metabolism. studying patients with ms who are overweight and obese may be relevant as obesity can cause chronic low-grade inflammation, potentially worsening ms symptoms. diet modification represents an interesting potential therapy for ms, particularly calorie restriction and fasting, which have been associated with reduced markers of inflammation. in addition to these direct effects, weight optimization may lead to improvements in ms-related symptoms, like fatigue, and overall quality of life. this is a single-blinded randomized trial of adherence to a dietary intervention in patients with ms who are receiving monthly natalizumab infusions. the study will evaluate how use of technology may help patients with ms adhere to a calorie restricted diet. it will also evaluate the effect of weight loss on fatigue and quality of life in patients with ms. a second part of the study will evaluate if shortening the period during the day in which people consume their typical food amounts leads to improvements in patient-reported outcomes.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥ 25 kg/m\^2 for calorie restriction study * bmi \< 25 kg/m\^2, or ≥ 25 kg/m\^2 if participant was unwilling to enroll in calorie restriction study * smartphone with the ability to download and use the loseit! application (calorie restriction only) * smartphone with the ability to take and store photos (calorie timing only) exclusion criteria: * history of diabetes requiring medication * currently pregnant or breastfeeding * history of an eating disorder * currently taking warfarin * history of major surgery within past 3 months

Keywords: calorie restriction weight loss
macrophage infiltration in human adipose tissue

Conditions: Obesity; Diabetes

Summary: quantification of macrophage infiltration and characterization of macrophage phenotype in adipose tissue of 60 obese subjects and 20 non obese subjects

obesity results from a disequilibrium in energy balance and an inability to adapt to lifestyles which encourage increased energy intake and sedentariness. these last years, numerous studies contributed to show that obesity is the pathology of an organ, the white adipose tissue (at), characterized by a low grade inflammation when it is enlarged. the fact that adipocytes secrete a number of inflammatory factors or "adipokines" has forced several groups to reassess the involvement of the at in wide range of physiological and pathophysiological processes. adipose tissue probably contributes to the links between obesity, inflammation and insulin-resistance. our previous results based on transcriptomics studies, showed that genes encoding inflammatory molecules are mobilized in adipose tissue of obese subjects and that caloric restriction improves greatly inflammatory profile. our preliminary studies on the morphology of adipose tissue lead us to observe a major infiltration of macrophages in morbidly obese subjects. this project is based on a clinical protocol performed in massively obese subjects (bmi\>40 kg/m²), where drastic weight loss is achieved by gastric bypass. this project has several objectives. it will allow us to characterize the infiltration of macrophages in the subcutaneous adipose tissue of 60 obese subjects compared with 20 normal-weight subjects, to study the evolution during surgically-induced weight loss and to compare the infiltration observed in adipose tissue to that of other tissues (visceral adipose tissue, muscle, liver, bowel and stomach). this study will be not only quantitative (number of macrophages) but also qualitative by characterizing the phenotype of macrophages with transcriptomics and immunohistochemical approaches. we will analyze the relationships between morphological characteristics of adipose tissue and clinical and biochemical parameters related to insulin sensitivity. more generally, this project might lead us to go thoroughly into the knowledge of the link between obesity and associated comorbidities, particularly metabolic complications, and to consider novels therapeutic strategies.

Eligibility criteria:
inclusion criteria: * obese subjects group : * obesity with bmi\> 40 kg/m² or obesity with bmi between 35 and 40 kg/m² with comorbidities (oas, diabetes, hypertension etc...) * age: 18-60 * non obese subjects group * abdominal surgery planned * age: 18-60 exclusion criteria: * inflammatory disease * cancer * stroke * drugs (ains)

Keywords: obesity macrophage infiltration insulinoresistance inflammation
metoclopramide for post traumatic headache

Conditions: Post-Traumatic Headache

Summary: nearly 1.5 million patients present to us emergency departments annually following head trauma. headache is a frequent symptom of victims of head trauma. the purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of patients with acute post-traumatic headache.


Eligibility criteria:
inclusion criteria: included patients will be adults who meet international classification of headache disorders criteria for acute post-traumatic headache. these are as follows: * traumatic injury to the head has occurred * headache has developed within 7 days of injury to the head * headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache) the headache must be rated as moderate or severe in intensity at the time of initial evaluation. exclusion criteria: patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, parkinson's disease, use of mao inhibitors, and use of anti-rejection transplant medications.
atrasentan and zometa for men with prostate cancer metastatic to bone

Conditions: Prostate Cancer; Adenocarcinoma of the Prostate

Summary: the main purpose of this study is to look at the effects (good or bad) that atrasentan given alone and atrasentan given with zometa has on levels of bone formation and bone destruction in men with prostate cancer that has spread to the bones.

* patients will be randomized to either receive atrasentan alone or atrasentan plus zometa. * patients receiving atrasentan alone will receive this drug in pill form once daily for 12 weeks. patients will have a physical exam, blood work, and a urine sample performed once every other week during the first four weeks of medication administration. after those two initial visits, they will return to the clinic once every 4 weeks to have the same tests repeated. a bone scan and abdominal-pelvic ct scan will be done every 12 weeks. * after the patient has been taking atrasentan for 12 weeks, if the disease has not progressed, they will begin combination treatment of atrasentan and zometa. * patients receiving atrasentan plus zometa, receive zometa intravenously and then immediately start atrasentan orally once daily as long as they remain on the study. patients will return to the clinic twice over the first 4 weeks (once every other week) to have a physical exam, blood work and urine test performed. after these two initial visits, they will return to the clinic once every 4 weeks to have the tests repeated and to receive another treatment of zometa. a bone scan and an abdominal-pelvic ct scan will be done once every 12 weeks. * patients participation in this study will last as long as the disease does not progress and they are not experiencing any serious side effects.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate * history of bilateral orchiectomy or current treatment with a gnrh agonist or antagonist * radiographically documented bone metastases * disease progression according to criteria from the psa working group exclusion criteria: * prior treatment with atrasentan or zometa within one year * serum creatinine \> 2.0mg/dl * documented cardiovascular disability status of new york heart association class 2 * treatment with chemotherapy, radiation, steroids, estrogens, or pc-spes within 6 weeks * treatment with bisphosphonates or radiopharmaceuticals within 12 weeks * history of paget's disease, hyperthyroidism, hyperparathyroidism, cushing's syndrome, hyperprolactinemia or other disorder associated with metabolic bone disease.

Keywords: prostate cancer bone metastases atrasentan zometa androgen independent prostate cancer
role of metabolic adaptation in weight regain

Conditions: Weight Loss; Weight Gain; Obesity

Summary: in a previous study (nct04081337), 55 participants with obesity participated on a 18-week lifestyle intervention to reduce their body weight, targeting 10% body weight loss. the participants received tirzepatide (15mg after titration) or placebo during the weight loss intervention. before and after the lifestyle intervention, energy expenditure (48-h room indirect calorimetry) and body weight and composition (dual-x-ray absorptiometry) were measured, thus enabling the assessment of metabolic adaptation. in this study, participants having provided their consent to be re-contacted will be invited to attend the research center 12,18 and 24 months after completing the lifestyle intervention. body weight and composition will be measured, aiming to explore the association between metabolic adaptation and changes in body weight and composition after a weight loss intervention. in addition, we will explore whether weight and fat mass changes are different between groups, and whether these effects are mediated by metabolic adaptation.


Eligibility criteria:
inclusion criteria: * having participated in the study nct04081337. exclusion criteria: * being pregnant.
efficacy and safety of nyx-2925 in subjects with fibromyalgia

Conditions: Fibromyalgia

Summary: to evaluate the efficacy of nyx-2925 versus placebo for the treatment of fibromyalgia.

this is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of nyx-2925 in subjects with fibromyalgia. this 13- to 16-week study will include a 1- to 4-week screening period followed by a 12-week double-blind, randomized, placebo-controlled treatment period.

Eligibility criteria:
inclusion criteria: * informed consent * subject has a history of fibromyalgia that was diagnosed \>1 year prior to screening and reports at least moderate pain over the last week * stable protocol allowed medication and other therapies during the study * agrees to use highly effective birth control during the study * has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study exclusion criteria: * pain due to other conditions or diseases that would complicate participation in the study or pain reporting * current or historical serious medical conditions * prior participation in nyx-2925 clinical trial
intratumoral budding (itb) in preoperative biopsies of colon and rectal cancer

Conditions: CRC

Summary: all the preoperative biopsies of patients suffering colorectal cancer (crc) will be immunohistochemically stained with a pancytokeratin marker to detect tumor buds. then, the intratumoral buds (itb) in the densest region of tumor buds, namely the "hot spot" will be counted. subsequently, the probability of n stage (lymphnodes), m stage (metastases) and disease free survival (dfs) will be calculated based on an existing logistic regression model already developed by our previous retrospective work. additionally, a standardisation of itb using a well- established software will develop an algorithm which will help to eliminate inter- observer variability of tumor budding counts.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed stages i and iv colorectal cancer (crc) * age ≥ 18 years * written informed consent exclusion criteria: * no consent * \< 18 years
heart rate variability modulation following a manipulation in pain free patients versus patients in pain

Conditions: Low Back Pain

Summary: background the purpose of this study was to examine the heart rate variability (hrv) in the presence or the absence of pain in the lower back (l5), while receiving chiropractic care. methods a total of 53 healthy participants were randomly assigned to a control, 2 treatment or 2 sham groups (n = 10 per group). participants underwent an eight-minute acclimatizing period. the hrv tachygram (rr interval) data were recorded directly into a suunto watch (model t6). the investigators analyzed the five minute pre-treatment and post treatments intervals. the spectral analysis of the tachygram was performed with the kubios software (university of kuopio, finland).

background the chiropractic profession has in the past utilized research results from other fields of and extrapolated them into their science and clinical interpretation 1-4. more recently, chiropractic researchers looked into autonomic nervous system (ans) adaptations in an animal model following a mechanical stress to the spinal column 5, a noxious mechanical stimulation 6 or a spinal manipulation 7. in the human model, several investigations have been done to measure modifications of the heart rate variability (hrv) following cervical 8 and thoracic manipulations 9 or in a multisite clinical study 10 where details of the manipulation site were not provided. the site of interest for the chiropractic intervention was defined at the level of the lumbar spine, left and right l-5. this site was selected because most studies 8-10 measuring hrv have used the cervical or thoracic component of the spine. the effect of the lumbar parasympathetic nervous system has not been evaluated. in these studies 8-10, changes were observed in various hrv variables, while in two of those studies 8, 9, where sham groups were included, the sham conditions did not demonstrate any changes in the reported hrv parameters. there are strong indications that hrv is a good marker of ans activity 19-24. thus, in the three above mentioned studies, it appears that chiropractic interventions have an effect on the ans. at present, however, no studies to evaluate whether a lumbar spinal manipulation would produce a change in the hrv have been reported. thus, the present study seeks to measure the effect of a lumbar adjustment, with a manually assisted mechanical force, producing a chiropractic adjustment, in participants without lumbar pain and a traditional adjustment in participants with lumbar pain on hrv. the hypothesis being that a lumbar intervention would have an acute effect on the ans as demonstrated by the modulation of hrv variables.

Eligibility criteria:
inclusion criteria: * acute low back pain (pain group) * maintenance care for the pain free group and the control group exclusion criteria: * for the control group (pain) * for the non pain group pain

Keywords: hrv activator chiropractic vlf hf lf lf/hf